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Improving cardiometabolic and mental health in women with gestational diabetes mellitus and their offspring: study protocol for MySweetHeart Trial, a randomised controlled trial
  1. Antje Horsch1,2,
  2. Leah Gilbert3,
  3. Stefano Lanzi3,4,
  4. Justine Gross3,
  5. Bengt Kayser5,
  6. Yvan Vial1,
  7. Umberto Simeoni6,
  8. Didier Hans7,
  9. Alexandre Berney8,
  10. Urte Scholz9,
  11. Ruben Barakat10,
  12. Jardena J Puder2,11
  13. on behalf of MySweetHeart Research Group
    1. 1 Woman-Mother-Child Department, Lausanne University Hospital, Lausanne, Switzerland
    2. 2 Institute of Higher Education and Research in Healthcare (IUFRS), University of Lausanne, Lausanne, Switzerland
    3. 3 Service of Endocrinology, Diabetes and Metabolism, Lausanne University Hospital, Lausanne, Switzerland
    4. 4 Service of Angiology, Heart and Vessel Department, Lausanne University Hospital, Lausanne, Switzerland
    5. 5 Institute of Sport Sciences, University of Lausanne, Lausanne, Switzerland
    6. 6 DOHad Laboratory, Pediatrics Division, Woman-Mother-Child Department, Lausanne University Hospital, Lausanne, Switzerland
    7. 7 Center of Bone Diseases, Rheumatology Service, Bone and Joint Department, Lausanne University Hospital, Lausanne, Switzerland
    8. 8 Consultation Liaison Psychiatry, Lausanne University Hospital, Lausanne, Switzerland
    9. 9 Applied Social and Health Psychology, Department of Psychology, University Research Priority Program Dynamics of Healthy Aging, University of Zurich, Lausanne, Switzerland
    10. 10 Facultad de Ciencias de la Actividad Física y del Deporte-INEF, Universidad Politécnica de Madrid, Madrid, Spain
    11. 11 Service of Pediatric Endocrinology, Diabetology and Obesity, Lausanne University Hospital, Lausanne, Switzerland
    1. Correspondence to Prof Antje Horsch; antje.horsch{at}chuv.ch

    Abstract

    Introduction Gestational diabetes mellitus (GDM) carries prenatal and perinatal risk for the mother and her offspring as well as longer-term risks for both the mother (obesity, diabetes, cardiovascular disease) and her child (obesity, type 2 diabetes). Compared with women without GDM, women with GDM are twice as likely to develop perinatal or postpartum depression. Lifestyle interventions for GDM are generally limited to physical activity and/or nutrition, often focus separately on the mother or the child and take place either during or after pregnancy, while their results are inconsistent. To increase efficacy of intervention, the multifactorial origins of GDM and the tight link between mental and metabolic as well as maternal and child health need to be heeded. This calls for an interdisciplinary transgenerational approach starting in, but continuing beyond pregnancy.

    Methods and analysis This randomised controlled trial will assess the effect of a multidimensional interdisciplinary lifestyle and psychosocial intervention aimed at improving the metabolic and mental health of 200 women with GDM and their offspring. Women with GDM at 24–32 weeks gestational age who understand French or English, and their offspring and partners can participate. The intervention components will be delivered on top of usual care during pregnancy and the first year postpartum. Metabolic and mental health outcomes will be measured at 24–32 weeks of pregnancy, shortly after birth and at 6–8 weeks and 1 year after childbirth. Data will be analysed using intention-to-treat analyses. The MySweetHeart Trial is linked to the MySweetHeart Cohort (clinicaltrials.gov/ct2/show/NCT02872974).

    Ethics and dissemination We will disseminate the findings through regional, national and international conferences and through peer-reviewed journals.

    Trial registration number NCT02890693; Pre-results.

    • gestational diabetes mellitus
    • physical activity
    • depression
    • eating behavior
    • social support

    This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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    Footnotes

    • Contributors JJP and AH designed the study with input from all other authors. AH and JJP drafted the manuscript and contributed equally to the present work. LG, SL, JG, BK, YV, USi, DH, AB, USc and RB significantly contributed to the establishment and refinement of study procedures and critically revised the manuscript. All authors approved the final version of the manuscript.

    • Funding This study is funded by a project grant by the Swiss National Science Foundation (SNF 32003B_176119).

    • Competing interests None declared.

    • Patient consent Obtained.

    • Ethics approval Ethical approval was granted by the Human Research Ethics Committee of the Canton de Vaud (study number 2016-00745).

    • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.

    • Data sharing statement Individual participant data collected during the trial (after deidentification) that underlie the publications from MySweetHeart research group will be available on reasonable request.

    • Collaborators The following are members of MySweetHeart Research Group (including the authors of the present article), listed in alphabetical order: Ruben Barakat, PhD, Professor (Facultad de Ciencias de la Actividad Física y del Deporte-INEF, Universidad Politécnica de Madrid, Madrid, Spain; barakatruben@gmail.com), Alexandre Berney, MD, Professor (Consultation Liaison Psychiatry, Lausanne University Hospital, Lausanne, Switzerland; alexander.berney@chuv.ch), Pascal Bovet, MD MPH, Professor (Institute of Social and Preventive Medicine (IUMSP), Lausanne University Hospital, Lausanne, Switzerland; pascal.bovet@chuv.ch), Jenni Brand-Miller, AM, FAIFST, FNSA, Professor (School of Life and Environmental Sciences and Charles Perkins Centre, University of Sydney, Australia; jennie.brandmiller@sydney.edu.au); Arnaud Chiolero, MD PhD, Senior lecturer (Institute of Social and Preventive Medicine (IUMSP), Lausanne University Hospital, Lausanne, Switzerland; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal Canada; Institute of Primary Health Care (BIHAM), University of Bern, Switzerland; arnaud.chiolero@chuv.ch), Stefano Di Bernardo, MD, Lecturer (Pediatric Cardiology Unit, Woman-Mother-Child Department, Lausanne University Hospital, Lausanne, Switzerland; stefano.di-bernardo@chuv.ch), Adina Epure, MD (Pediatric Cardiology Unit, Woman-Mother-Child Department; Institute of Social and Preventive Medicine (IUMSP), Lausanne University Hospital, Lausanne, Switzerland; adina-mihaela.epure@chuv.ch), Sandrine Estoppey, M.Sc. (Institute of Social and Preventive Medicine (IUMSP), Lausanne University Hospital, Lausanne, Switzerland; sandrine.estoppey@chuv.ch), Leah Gilbert, M.Sc. (Service of Endocrinology, Diabetes and Metabolism, Department of Medicine, Lausanne University Hospital, Lausanne, Switzerland; leah.gilbert@chuv.ch), Elena Gonzalez-Rodriguez, MD (Service of Endocrinology, Diabetes and Metabolism, Department of Medicine, Lausanne University Hospital, Lausanne, Switzerland; elena-gonzalez@chuv.ch), Justine Gross, HES (Service of Endocrinology, Diabetes and Metabolism, Department of Medicine, Lausanne University Hospital, Lausanne, Switzerland; justine.gross@chuv.ch), Didier Hans, MD (Center of Bone Diseases, Rheumatology Service, Bone & Joint Department, Lausanne University Hospital, Lausanne, Switzerland; didier.hans@chuv.ch), Antje Horsch, DClinPsych, Professor (Institute of Higher Education and Research in Healthcare (IUFRS), University of Lausanne and Woman-Mother-Child Department, Lausanne University Hospital, Lausanne, Switzerland; antje.horsch@chuv.ch), Bengt Kayser, MD, PhD, Professor (Institute of Sport Sciences, University of Lausanne; bengt.kayser@unil.ch), Stefano Lanzi, PhD (Service of Endocrinology, Diabetes and Metabolism, Department of Medicine and Service of Angiology, Heart and Vessel Department, Lausanne University Hospital, Lausanne, Switzerland; stefano.lanzi@chuv.ch), Yvan Mivelaz, MD, Lecturer (Pediatric Cardiology Unit, Woman-Mother-Child Department, Lausanne University Hospital, Lausanne, Switzerland; yvan.mivelaz@chuv.ch), Jardena J Puder, MD, Professor (Service of Endocrinology, Diabetes and Metabolism, Department of Medicine and Service of Pediatric Endocrinology, Diabetology and Obesity, Lausanne University Hospital, Lausanne, Switzerland; jardena.puder@chuv.ch), Dan Quansah, MPH (Service of Endocrinology, Diabetes and Metabolism, Department of Medicine, Lausanne University Hospital, Lausanne, Switzerland), Urte Scholz, PhD, Professor (Applied Social and Health Psychology, Department of Psychology & University Research Priority Program Dynamics of Healthy Aging, University of Zurich, Zurich, Switzerland; urte.scholz@psychologie.uzh.ch), Nicole Sekarski, MD, Professor (Pediatric Cardiology Unit, Woman-Mother-Child Department, Lausanne University Hospital, Lausanne, Switzerland; nicole.sekarski@chuv.ch), Umberto Simeoni, MD, Professor (DOHad Laboratory, Pediatrics Division, Woman-Mother-Child Department, Lausanne University Hospital, Lausanne, Switzerland; umberto.simeoni@chuv.ch), Benazir Siddeek, Ph.D. (DOHad Laboratory, Pediatrics Division, Woman-Mother-Child Department, Lausanne University Hospital, Lausanne, Switzerland; benazir.siddeek@chuv.ch), Yvan Vial, MD, Professor (Obstetrics and Gynecology Division, Woman-Mother-Child Department, Lausanne University Hospital, Lausanne, Switzerland; yvan.vial@chuv.ch).

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